Head and neck squamous cell carcinoma (HNSCC) affects 50,000 people in the United States and 600,000 people world-wide each year. The main risk factors include tobacco and alcohol use and human papillomavirus (HPV) infection.
To date, there is no widely accepted HNSCC screening program or test (see, e.g., Vokes et al., N Engl J Med, 328:184-94 (1993); Lingen et al., Curr Opin Oncol, 13:176-82 (2001); Forastiere et al., N Engl J Med 345:1890-1900 (2001); Patton, Orol Oncol, 39:708-723 (2003); O'Hara et al., Clin Otolaryngol, 27:133-4 (2002); Smart, Cancer 72:1061-5 (1993); Sankaranarayanan et al., Cancer, 88:664-73 (2000); Sankaranarayanan et al., Lancet 365:1927-33 (2005)) because the gold standard, screening by physical exam followed by biopsy, has limited sensitivity and specificity (64% and 74%, respectively) (Brocklehurst et al., Cochrane Database Syst Rev, 11:CD004150 (2010)) and molecular diagnostic tests are still under development (Nagler, Oral Oncol., 45:1006-10 (2009); Mahfouz et al., Eur Arch Otorhinolaryngol, 267:851-60 (2010)). Adjunctive techniques for oral cancer detection that use dyes, autofluorescence, or exfoliative cytology are available, but recent reviews question whether they improve early detection rates (Patton et al., J Am Dent Assoc, 139:896-905 (2008); Lingen et al., Oral Oncol 44:10-22 (2008)). Therefore, efforts have focused on molecular diagnostic tools. Several studies that tested saliva for RNA expression profiles (Li et al., Clin Cancer Res, 10:8442-8450 (2004)), microRNA discovery (Park et al., Clin Cancer Res, 15:5473-5477 (2009)) and proteomic analysis (Hu et al., Clin Cancer Res, 14:6246-6252 (2008)) show promise but are somewhat complicated and not validated (Nagler, Oral Oncol., 45:1006-10 (2009); Mahfouz et al., Eur Arch Otorhinolaryngol, 267:851-60 (2010)). As a result, the majority of patients are diagnosed at a late stage, when cure rates are 40% or lower. Thus, early detection tests are needed.